NRC Non-Rinse Conditioner

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K992519 ↗

FDA Product Code

EBC

Device Class

Class II

Regulation

21 CFR Part 872.3765

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• What is the NRC Non-Rinse Conditioner used for in dental procedures?

  The NRC Non-Rinse Conditioner is designed to prepare enamel surfaces for dental sealants by conditioning the tooth without requiring a rinse step. This simplifies the application process and helps minimize moisture contamination on the tooth surface, which can interfere with sealant adhesion. By improving surface preparation, it enhances the effectiveness of sealants in protecting teeth from cavities.

• Is the NRC Non-Rinse Conditioner single-use or reusable?

  The NRC Non-Rinse Conditioner is supplied as a single-use dental product. This ensures sterility and reduces the risk of cross-contamination between patients, which is critical in clinical settings where hygiene and infection control are paramount.

• How is the NRC Non-Rinse Conditioner packaged and stored?

  The NRC Non-Rinse Conditioner comes in sterile packaging, which maintains its sterility until use. It should be stored according to the manufacturer’s guidelines—typically in a cool, dry place away from direct sunlight and extreme temperatures. Always check the packaging for expiration dates and ensure the seal remains intact before use.

• What regulatory classification does the NRC Non-Rinse Conditioner hold?

  The NRC Non-Rinse Conditioner is classified as a Class II medical device under FDA regulations and holds a 510(k) clearance (K992519) with a Substantially Equivalent (SESE) determination. This classification indicates it has undergone rigorous review to ensure safety and effectiveness for its intended use in dental procedures.

• Does the NRC Non-Rinse Conditioner require any special handling or disposal procedures?

  As a single-use dental product, the NRC Non-Rinse Conditioner should be disposed of after use in accordance with local healthcare waste regulations. Since it is sterile and intended for one-time use, it should not be reused or shared between patients. Always follow your facility’s protocols for sharps and biohazardous waste disposal to ensure compliance and safety.